Trial Outcomes & Findings for A Systems-Level Intervention for Rural Adults With Depression (NCT NCT04502186)
NCT ID: NCT04502186
Last Updated: 2025-02-04
Results Overview
Participants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), and 12-weeks post-treatment
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Raising Our Spirits Together Intervention
Raising Our Spirits Together: Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
|
Enhanced Control Condition
Enhanced Control Condition: The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
30
|
|
Overall Study
COMPLETED
|
29
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Systems-Level Intervention for Rural Adults With Depression
Baseline characteristics by cohort
| Measure |
Raising Our Spirits Together Intervention
n=40 Participants
Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
|
Enhanced Control Condition
n=30 Participants
The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.63 years
STANDARD_DEVIATION 15.26 • n=5 Participants
|
39.57 years
STANDARD_DEVIATION 13.68 • n=7 Participants
|
43.03 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
30 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), and 12-weeks post-treatmentParticipants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome)
Outcome measures
| Measure |
Raising Our Spirits Together Intervention
n=40 Participants
Raising Our Spirits Together: Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
|
Enhanced Control Condition
n=30 Participants
Enhanced Control Condition: The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
|
|---|---|---|
|
Change in Self-report Measure of Depressive Symptoms
PHQ-9 Baseline
|
13.90 score on PHQ-9
Standard Deviation 5.49
|
13.43 score on PHQ-9
Standard Deviation 4.40
|
|
Change in Self-report Measure of Depressive Symptoms
PHQ-9 Post-treatment
|
7.00 score on PHQ-9
Standard Deviation 5.67
|
7.57 score on PHQ-9
Standard Deviation 4.03
|
|
Change in Self-report Measure of Depressive Symptoms
PHQ-9 Follow-up
|
7.72 score on PHQ-9
Standard Deviation 7.36
|
8.10 score on PHQ-9
Standard Deviation 5.51
|
Adverse Events
Raising Our Spirits Together Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Enhanced Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Raising Our Spirits Together Intervention
n=40 participants at risk
Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
|
Enhanced Control Condition
n=30 participants at risk
The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
|
|---|---|---|
|
Social circumstances
Protocol Deviation
|
2.5%
1/40 • Number of events 1 • Adverse event data was collected for each participant from the time of enrollment through study completion, which was, on average, 6 months.
|
0.00%
0/30 • Adverse event data was collected for each participant from the time of enrollment through study completion, which was, on average, 6 months.
|
Additional Information
Dr. Addie Weaver
University of Michigan School of Social Work
Phone: 734-615-2122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place